HEMAGO Monitoring and Impact on the Occurrence of Complications During Pregnancy in Sickle Cell Patients
- Conditions
- Sickle Cell Disease and Pregnancy
- Interventions
- Other: Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies.
- Registration Number
- NCT06620887
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Sickle cell disease is the most common monosemic genetic disease in the world and affects approximately 32,000 people in France. In recent years, improvements in the management of this pathology have led to a steady increase in the life expectancy of sickle cell patients.
Women with sickle cell disease are increasingly likely to have one or more pregnancies.
Several studies have shown that these pregnancies are marked by maternal morbidity due to acute sickling crises, thromboembolism, infection, chronic end-organ dysfunction, or pre-eclampsia (PE), while neonatal outcomes may be intrauterine growth retardation (IUGR), preterm delivery, small infants for gestational age, stillbirth, and neonatal death.
Consequently, monitoring pregnancies in sickle cell patients represents a complex medical challenge due to the risk of potentially serious maternal and fetal complications. Multidisciplinary follow-up is then crucial to monitor and manage these possible complications.
The double hematologist-obstetrician consultation program (HEMAGO) offers complete and adapted close follow-up, in order to minimize the risks for the mother and the unborn child.
This study aims to evaluate the impact of this HEMAGO monitoring on the various maternal and obstetric complications by comparing the outcome of pregnancies of patients who were followed before the implementation of this device to patients who were followed in the frame their pregnancy through this program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- sickle cell disease female
- followed up for at least one pregnancy in the maternity of Croix-Rousse Hospital, Femme Mère Enfant Hospital and Lyon Sud Hospital
- Minor woman
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnancies before HEMAGO Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies. Pregnancies follow-up before HEMAGO : complications and outcomes of pregnancies in sickle cell patients which had a classical follow-up. Pregnancies HEMAGO following-up Evaluate the impact of HEMAGO program on maternal morbidity and mortality in sickle cell disease patients during their pregnancies. Pregnancies in sickle cell patients follow-up by HEMAGO : complications and outcomes of pregnancies in sickle cell disease patients which were monitored by HEMAGO program.
- Primary Outcome Measures
Name Time Method Composite criterion including in the mother : Maternal complications → Obstetrics complications → Sickle cell complications → intensive care hospitalization → death ? These are follow-up consultations once a month until 24 weeks then every 15 days until delivery. comparing results before (January 2005 to March 2016) and after HEMAGO (April 2016 - February 29, 2024) Maternal complications :
* Obstetrics complications : pre-eclampsia or Hellp syndrome / intra-uterine growth restriction (IUGR) / preterm labor / chorioamniotis / intrauterine death
* Sickle cell complications (vaso-occlusive crisis (VOC) / acute chest syndrome / cerebral stroke)
* lung or urinary infections
* thromboembolism
* intensive care hospitalization
collection of data done by rereading obstetric records by a single person.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Service de gynécologie-obstétrique de l'Hôpital Femme Mère Enfant
🇫🇷Bron, France
Croix-Rousse Hospital - Service de Gynécologie-Obstétrique
🇫🇷Lyon, France
Service de gynécologie-obstétrique de l'Hôpital de Lyon Sud
🇫🇷Lyon, France